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Disclosure

Curricular Objectives

  1. To know the elements of disclosure, and the standards for disclosure
  2. To be able to perform a competent disclosure regarding a proposed treatment

Summary of Case

Mr. Appelbaum is a 61 year old man who works as a supervisor at the Ford Motor Company. He is married and lives at home with wife. His two children are grown and live in the United States. He is previously healthy with no medical problems or previous surgeries, and he has a normal exercise tolerance.

Two weeks ago, he had an episode of transient monocular blindness in his left eye. He attended his family doctor's office the next day at which time he was started on aspirin 325 mg once per day. A duplex doppler ultrasound revealed significant stenosis of the left internal carotid artery. He underwent cerebral angiography 3 days later, which revealed a 90% stenosis of the left internal carotid artery just distal to the bifurcation of the common carotid artery. The rest of his angiogram is normal. His cardiac examination and 12 lead electrocardiogram are also normal.

The family doctor has suggested that Mr. Appelbaum have a left carotid endarterectomy for his symptomatic arotid stenosis. Endarterectomy reduces the risk of major stroke 2 years after surgery from 13% to 3%. The perioperative risk is 5% for stroke and 1% for mortality. Mr. Appelbaum is in the office today to discuss the proposed surgery with you.


Lesson Plan

This lesson plan provides a guide for the facilitated discussion of disclosure of risks and benefits of a procedure. In a 1 hour session, about 20 minutes is devoted to the case. The facilitated discussion is based on a short review of all of the elements of consent. The lesson plan is outlined as a series of questions the instructor might ask the group. Viewpoints to which the group should be exposed in the facilitated discussion are presented.

Question 1:

Has the patient been adequately informed?

Answer:
Take a pedagogic vote. The patient is adequately informed if he/she has been told all that a reasonable person in his/her same circumstances would want to know of the planned treatment, and the risks and benefits of alternatives including no treatment.

Question 2:

What is your standard for disclosure? Do you give the patient statistics from the literature? Are you required to give them a mini course in medicine? What is the standard by which adequate disclosure is judged?

Answer:
Professional Standard: The professional standard of disclosure which is the legal standard in the United Kingdom and other jurisdictions is based on "What other physicians normally disclose." This might include a statement about what the consensus of the literature and the practice community recommend for treatment. It does not include particular details related to the patients' unique circumstances and does not require detailed discussion of time in the hospital, nor extent of disability in the short and intermediate term.
Reasonable Person: The reasonable person's standard is the legal standard in the United States and was for many years, the legal standard in Canada. It includes disclosure "what any reasonable person would want to know in making a decision about the surgery." This standard includes more of the details related to inconvenience as well as risk.
Particular Person: The particular person's standard of disclosure is the legal standard in Canada. This standard requires that the patient be told what any reasonable person in the same particular circumstances as the patient would want to know in making the decision. This standard includes a consideration of particular details of the patient's life which may impinge upon the appropriateness of the decision. It is based on the case of Reibl vs. Hughes, a standard setting legal case which held that the surgeon was at fault for not taking into consideration the patient's future vesting in his company's disability and retirement plan when making a decision about an operation which could result in life long disability.
A second important issue in this case was the requirement that the patient not only receive or be exposed to the information but must comprehend it.
A discussion of Reibl vs. Hughes along the lines of the presentation in Kluge may be developed at this time.

Question 3:

What risks must be disclosed in the discussion of a planned procedure or treatment?

Answer:
The material risks, that is, those that are common and those that are serious must be disclosed to the patient. For example, a bronchial arteriogram and embolization for haemoptyses requires disclosure of the common risk of haematoma and the serious, though extremely rare, complications of paraplegia.

Question 4:

Why not give the patient an article to read about the procedure and a complete set of statistics on outcomes?

Answer:
Some surgeons, particularly those who have had a bad experience in a law suit related to informed consent, tend to choose this extreme. The courts have found that statistical information is not comprehended by patients and is often contradictory. Drowning the patient in technical details can be a punitive act. It does not discharge the fiduciary responsibility of the surgeon to provide the information that a reasonable person in the same particular circumstances would want to know about treatment and its alternatives. Some surgeons provide written material that is clear and comprehensible for the patient to take home, or information in video format. These can be helpful but they should not substitute for talking to the patient and assuring comprehension.


Bioethics Bottom Line

The physician should inform the patient about any proposed diagnostic tests and treatments. The key elements of such disclosure include the risks and benefits of the proposed test or treatment as well as any alternative tests or treatment. The extent of disclosure in emergencies may be less detailed because of urgency and lack of information, e.g., when an urgent laparotomy is performed for life threatening vehicular trauma. While emergencies may require such a paternalistic standard, elective treatments require a level of disclosure that is sufficient to allow the patient or surrogate to make an informed choice regarding treatment. Although standards for disclosure may vary from one jurisdiction to another, the physician should disclose all the information that a reasonable person in the patient's situation would want or need to know before making a decision. This would include information about any material risks, that is, risks that are likely or serious.

It is prudent for the physician to explain any benefits, risks or alternative tests or treatments that may have special significance for the particular patient. For example, any risk of upper extremity peripheral neuropathy should be disclosed to a concert violinist, and the alternative of delaying a surgical procedure should be disclosed to a person who is only a few months away from receiving his/her pension. The use of video tapes and written information may be helpful, but should not substitute for direct discussion with the patient, who should have the opportunity to have questions answered directly. The information should be presented in language the patient can understand, and the physician should ensure that the patient has actually understood it.

The justification for disclosure related to proposed diagnostic tests and treatments is the same as that for consent generally. The patient has a right to decide about treatment grounded in the principle of respect for autonomy. A competent voluntary decision requires information to be provided by the physician. This communication is an essential component of the physician-patient relationship, grounded in the principle of beneficence, and the physicians' primary obligation of service to their identified patients.


References

Etchells EE, Sharpe G, Burgess M, Singer PA. Bioethics for clinicians: 2. Disclosure. CMAJ 1996; 155:387-91.

Informed consent and the competent patient: introduction; Reibl v. Hughes. In: Kluge, Eike-Henner W, editors. Readings in biomedical ethics: A Canadian focus. Scarborough: Prentice Hall Canada; 1993. p. 129-142.

Further Readings

Katz J. Physicians and patients: a history of silence. In: Beauchamp TL, Walters L, editors. Contemporary issues in bioethics. 4th ed. Belmont: Wadsworth Publishing Co.; 1994. p. 145-8.

Katz J. The silent world of doctor and patient. New York: Free Press; 1984.


Teaching Aid: Standardized Patient Case

Summary of Case
Mr. Appelbaum is a 61 year old man who works as a supervisor at the Ford Motor Company. He is married and lives at home with wife. His two children are grown and live in the United States. He is previously healthy with no medical problems or previous surgeries, and he has a normal exercise tolerance.

Two weeks ago, he had an episode of transient monocular blindness in his left eye. He attended his family doctor's office the next day at which time he was started on aspirin 325 mg once per day. A duplex doppler ultrasound revealed significant stenosis of the left internal carotid artery. He underwent cerebral angiography 3 days later, which revealed a 90% stenosis of the left internal carotid artery just distal to the bifurcation of the common carotid artery. The rest of his angiogram is normal. His cardiac examination and 12 lead electrocardiogram are also normal.

The family doctor has suggested that Mr. Appelbaum have a left carotid endarterectomy for his symptomatic arotid stenosis. Endarterectomy reduces the risk of major stroke 2 years after surgery from 13% to 3%. The perioperative risk is 5% for stroke and 1% for mortality. Mr. Appelbaum is in the office today to discuss the proposed surgery.

More than one resident should have a chance to talk to the patient "in character" by coming to the front of the room and sitting down with the patient to explain the risks and benefits of the planned procedure.

Instructions to Resident
You are a junior resident on the surgical team. You are about to see Mr. Appelbaum. Mr. Appelbaum experienced temporary blindness in his right eye two weeks ago. An angiogram ordered by the family doctor indicated a blocked carotid artery. Mr. Appelbaum is currently at the office today for an explanation of what needs to be done. A carotidectomy seems in order.

Instructions to Standardized Patient

Demographics

  • Male. Close to retirement age.

Chief Complaint

  • Your family doctor has sent you to see a vascular surgeon at the Toronto Hospital, General Division.

History of Problem

  • Suddenly, 2 weeks ago, you couldn't see out of your left eye. You were at work at the time. It was like a black curtain going down over your left eye. You covered your right eye and realized you couldn't see a thing. You sat down for a while. After about 10 minutes, everything was fine and you resumed work.
  • That evening you told your wife happened. She insisted that you see her family doctor the next day.
  • The family doctor told you to start taking aspirin, and arranged for an ultrasound of your neck to be done. Ultrasound was done within a few days. 3 days later, you had an angiogram done. You were told that the family doctor would let you know about the results and you were sent home.
  • The family doctor told you there was a problem with your artery and that you should see a surgeon. That's why you are at the hospital now.

Past Health History

  • Very healthy in general.
  • No operations.
  • No hospitalizations.
  • No medications (except aspirin that doctor recommended).
  • You had BP checked 3 years ago on wife's insistence and it was OK.

Family History

  • Unremarkable.
  • No major illnesses or disease.

Social History

  • Married for 40 years.
  • 2 grown children.
  • You work on the assembly line at the Ford Motor Plant.

Questions You May Have About The Operation

  • I'm not having any problems now. Why do I need surgery?
  • What kind of operation is it? Is it a little operation or do I have to go under?
  • Who would do the surgery? What are you going to do?
  • Is it dangerous? Is it common?
  • Do I have to do it? What happens if I don't have it done?
  • What would you do? What if it was your father?
  • Do I have to tell you right now?
  • I'm nervous.

Additional Training Instructions
As "Mr. Appelbaum", you are not medically sophisticated. You may be a little overwhelmed by medical jargon, but not inclined to admit it.

The doctor should check your understanding of what has been said. Therefore, listen to everything but don't repeat it back to doctor. Wait for doctor to ask what you've heard.

Information about the angiogram: First, a needle is used to "freeze" your groin. It hurts when they put the freezing in. Then dye is injected. You felt warm all over after the injection. Then X-rays are taken. With an angiogram it is possible to see if there are "blockages" in the arteries.

Prompts
If needed:

  • Am I allowed to ask questions?
  • Is there a risk from the anaesthesia?
  • What are my chances of having a stroke if I don't have the operation? (ie., "What if I don't have it?)
  • What are my chances of having a stroke if I do have it? (ie., What if I do?)
  • What else could go wrong?
  • How would it be if I waited 6 months?
  • Do I have to have it? Is it an emergency?

If doctor gives an explanation of the operation, and doesn't ask if you understand, then you may ask, "How can operating on my neck fix my eye?"

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